A prospective study of complications of endoscopic retrograde cholangiopancreatography and endoscopic ultrasound in an ambulatory endoscopy center.

BACKGROUND AND AIMS: Our aim was to assess the safety of endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic ultrasound (EUS) in an ambulatory endoscopy center (AEC).

METHODS: Complications occurring in consecutive patients undergoing ERCP or EUS from March 2003 to February 2004 at our AEC were recorded prospectively. Comprehensive complications were defined as consensus criteria plus other adverse events: use of reversal agents, unplanned hospital admission, hospitalization beyond planned 23-hour observation, unplanned emergency department or primary care provider visit, and 30-day mortality.

RESULTS: A total of 497 patients (median age, 57 y; 82% American Society of Anesthesiologists class II or III) underwent 685 procedures. Monitored or general anesthesia was used in 25% of EUS and 50% of ERCP procedures. ERCP interventions were as follows: biliary or pancreatic stenting (N = 168), stone extraction (N = 70), sphincterotomy (N = 62), sphincter of Oddi manometry (N = 53), other (N = 66). EUS indications were as follows: known or suspected pancreatic mass (N = 103), upper-gastrointestinal mass/submucosal lesion (N = 71), luminal malignancy staging (N = 40), other (N = 96); 52% had EUS fine-needle aspiration. There was follow-up evaluation in 94% of the patients. There were 43 comprehensive ERCP complications (12.9%), 18 (5.4%) of these fit consensus criteria: pancreatitis (N = 14), cholangitis (N = 2), and perforation (N = 2). There were 9 comprehensive EUS complications (2.9%), 2 (.7%) of these fit consensus criteria: pancreatitis (N = 1) and bleeding (N = 1). Other adverse events for ERCP and EUS were as follows: prolongation of 23-hour observation (N = 14), emergency room visits (N = 3), primary care physician visits (N = 6), use of reversal agents (N = 3), unplanned admissions (N = 2), infection (N = 3), and death (N = 1).

CONCLUSIONS: ERCP and EUS can be performed in an AEC, provided mechanisms for admission and anesthesia support are in place. The assessment of comprehensive complications is more reflective of adverse events related to ERCP and EUS than consensus criteria alone.